Prescription drug · ANDA
Vancomycin Hydrochloride NDC 42494-451
Vancomycin hydrochloride 250 mg/1 · Capsule · Oral · Cameron Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42494-451-20 | 42494045120 | 2 BLISTER PACK in 1 CARTON (42494-451-20) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jan 15, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Vancomycin Hydrochloride
- Generic name (nonproprietary)
- vancomycin hydrochloride
- Active ingredients
- Vancomycin hydrochloride — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Cameron Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210729
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 42494-451_59468bc9-8c3b-6b7a-e063-6294a90a9b42SPL ID 59468bc9-8c3b-6b7a-e063-6294a90a9b42SPL set ID bc737938-ae36-460b-a2a8-609f3fe59156RxCUI 313570, 313571UNII 71WO621TJD
- Pharmacologic class
- Glycopeptide Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N442494045120followed by a unit qualifier and the quantityPackage 42494-0451-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Vancomycin Hydrochloride Capsules are indicated for the treatment of C. difficile -associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Vancomycin hydrochloride capsules are glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) C. difficile -associated diarrhea Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) Limitations of Use : ( 1 ) ( 5.1 ) Parenteral administration of vancomycin is not effective for…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210729
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Vancomycin Hydrochloride | Vancomycin hydrochloride 125 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2305 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2306 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 125 mg/1 | CapsuleOral | Cameron Pharmaceuticals | 42494-450 |
| vancomycin hydrochloride | Vancomycin hydrochloride 125 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-967 |
| vancomycin hydrochloride | Vancomycin hydrochloride 250 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-968 |